Auditing Qms p1

Auditing Process-based
Quality Management Systems

Charlie Cianfrani and Jack West
C. A. Cianfrani & J. E. West

January, 2013
Agenda
Course objectives
What is an audit?
How to prepare for and plan an audit
How to conduct an audit
How to report on an audit
Course closing

January, 2013
Course Objectives
Learn the basics of performing internal
audits of a QMS based on the process
approach
Process mentality
Consider policy, objectives, processes,
products and organizational alignment
Prepare an audit plan
Conduct an audit
Document findings
Write an audit report
Ensure follow-up on corrective actions

January, 2013
Agenda
Course objectives
Introductions
What is an audit?
How to prepare for and plan an audit
Course closing

January, 2013
What is an audit?
An audit* is a systematic, independent
and documented process for obtaining
audit evidence and evaluating it
objectively to determine the extent to
which audit criteria are fulfilled
* Definition is from both
ISO 9000:2005 Quality management systemsFundamentals and vocabulary
ISO 19011:2011 Guidelines for quality and/or
environmental management systems auditing
January, 2013
What is an internal audit?
An internal quality audit is an

audit that is performed by or
at the direction of members
of the organization

January, 2013
Why audit?
Possible reasons to audit:
ensure compliance with ISO 9001:2008
ensure compliance with organization
requirements
ensure compliance with regulatory
requirements
ensure the QMS is effectively implemented
and maintained

January, 2013
Why audit? (continued)

Auditing for improved performance
look for opportunities for improvement
look for best practices that could be applied in
other areas
look for preventive action
look for outstanding emphasis on customer
satisfaction

January, 2013
Principles of auditing
Ethical conduct
Fair presentation
Professional care
Independence
Objectivity
Impartiality
Evaluations based on evidence
Competence
Cooperation
Trust

January, 2013
Audit vs. Management Review vs. Self-assessment
Three complementary concepts:

What do we mean by self-assessment?
- ISO 9004:2009 Annex A
- Baldrige
What do we mean by management review?

They are all approaches to ensuring effectiveness,
efficiency, improvement and customer satisfaction

January, 2013
Three Types of Audits

External independent audits third party
Customer audits of suppliers second party
Internal audits first party

January, 2013

External independent audits third party
Conformity to a specific standard
REGISTRAR
STANDARD (9001)
ORGANIZATION

January, 2013
LIST
CUSTOMER

Customer audits of suppliers second party
Conformance to customer requirements
Customers special interest items
STANDARD (e.g. ISO 9001)
OTHER REQUIREMENTS
ORGANIZATION

January, 2013
CUSTOMER

Internal audits first party
Performance to the
organizations objectives
Identification of problem
areas!
Finding opportunities for
improvement!

January, 2013
The Process Approach

Evolving nature of quality management
Internal focus vs. customer focus
Control vs. improvement
QA by QA vs. QA by organization
Leadership: from QA or from management
Documented procedures vs. manage processes
Independence of QA vs. integration
Alignment of business, policy and objectives

January, 2013
Remember the quality management principles?
Principle #4 Process Approach

A desired result is achieved more efficiently when
activities and related resources are managed as a
process.
Principle #5 System approach to

management
Identifying, understanding, and managing
interrelated processes as a system contributes to
the organization's effectiveness and efficiency in
achieving its objectives
January, 2013
Process
A group of interrelated activities and related
resources that transforms inputs into outputs
Controls
Activity
Activity
Activity
Output
Input
Process
Resources
January, 2013
System: A Family of Well Managed Processes

Driven by Top Management
Continually Improving Effectiveness
Process
Process
Process
Process
Process
Network of Interrelated Processes

January, 2013
C
U
Focused S
on
T
O
M
E
R
The SIPOC Model of a Process

Inputs
Inputs
Suppliers
Suppliers
Outputs
Outputs
Process
Process
Requirements
&
Feedback
Customers
Customers
Requirements
&
Feedback
The SIPOC model (suppliers, inputs, processes, outputs, customers)

shows linkage of:
processes from suppliers to final customers

feedback from customers to the organization
feedback from the organization to suppliers (see pg 16 in audit book)
January, 2013
ISO 9001 and Auditing

Audits are covered in clause 8.2.2 of ISO
9001:2008 which is part of section 8
Measurement, analysis and improvement
Emphasizes determining effective
implementation and maintenance of the
quality management system
Note: the overall effectiveness of
the Quality management system
is the responsibility of top management
January, 2013
Agenda
Introductions
Course objectives
What is an audit?
How to prepare for and plan audits
Course closing

January, 2013
Planning the Audit Program

January, 2013
The Audit Process An Overview

Management
Input
Policy
History
Documents
Customer
feedback
Planning
January, 2013
Review results
Use results
Internal
Internal
auditaudit
Resources
Provide resources
Output
Audit Report
Findings/CARs
Information
Follow-up
Time
Improvement
Trained
Conclusions
personnel
Audit Conclusions
Audit output conclusions may include:
Conclusion regarding the conformance of the

audited process to ISO requirements
Statements regarding the suitability of a process
to achieve objectives
Comments regarding the effective
implementation of a process
Suggestions for consideration regarding
possibilities for improvement

January, 2013
Administrative Issues to Address

Typically an audit boss is assigned by management
to oversee the internal audit process
Clear charter for the internal audit process
Tie with other auditing (e.g., finance, EMS)
Overall audit plan/schedule?
How is input provided to management review?
Analysis of audit process and results?

January, 2013
Auditor Criteria
Need knowledge and skills in
Audit principles, procedures and techniques

Management system including quality management
Organizational understanding
Specific process and product knowledge
Social interaction
Consider guidance in ISO 19011

Education and experience
Competence
January, 2013
Lead Auditor Criteria

Audit team leaders need to be able to:
Plan audits
Effectively communicate with auditees
Organize and direct audit team members
Lead team in reaching conclusions
Prevent and resolve conflicts
Coach auditors-in-training
Consolidate team inputs and prepare great
reports
January, 2013
Making an Audit Schedule
List main activities (processes)

List departments involved with the QMS
Decide what activities to audit in what departments
Be sure to include quality-relevant supporting
activities
Be sure to include ISO system-level activities
Check to ensure coverage of all pertinent activities
Assign individuals or teams to perform audits

January, 2013
Audit Process Overview

Prepare
for the
audit
Perform
the audit
Report the
results
Perform
corrective
action

January, 2013
The Audit Process - Overview

Prepare detailed plans for each audit
Execute each audit
Report audit results including conclusions and
recommendations
Corrective actions if needed
Follow-up to ensure corrective actions are
effective

January, 2013
Audit Approaches
Horizontal audit audit of one system across several
functional groups (one thing-many places)
audit across several groups to evaluate if a consistent
approach is being followed e.g. for competence (Clause 6.2)
Vertical audit audit each function (department) of the
organization and audit all processes in each function (many
things-one place)
audit within a manufacturing cell for process performance,
product compliance, data analysis, corrective action,
improvement etc., etc., Clauses 7.1, 7.5, 8..4, 8.5.2 etc.
Some combination of all of the above
e.g. QA performs QMS audits (horizontal) and trained
not full time auditors perform function audits
(vertical)
January, 2013
Planning Individual Audits

January, 2013
Prepare for an Audit
Define audit objectives

Typically done
Define audit scope
by audit boss
Define audit resources
Define audit criteria
Prepare and distribute an audit notification to
auditee
Gather and understand relevant documents
Prepare work plan i.e. audit plan

January, 2013
Audit Objectives
Compliance and improved effectiveness?
(Required by ISO 9001!)
Improved efficiency?
(Perhaps needed for survival!)
Both?

January, 2013
Audit Scope
What are the boundaries of an audit?

What processes will we audit?
What organizational functions are included?
What is the audit emphasis?
What is the timeframe?

January, 2013
Audit Resources
Who will audit? A team? An individual?
If a team, who will be the lead auditor?
Do we have appropriate personnel (i.e. do we
need any special technical expertise?

January, 2013
Audit Criteria
What policies, procedures, instructions or other
requirements will we use as a reference?
External requirements?
Internal requirements?

January, 2013
Audit implies comparison to criteria

January, 2013
Must audit criteria be in writing?
Your Opinion?

January, 2013
Examples of Audit Criteria - Internal

Standard operating
procedures
Quality system
procedures
Training procedures
Calibration procedures
Startup/shutdown
procedures
Maintenance
procedures
January, 2013
Emergency
procedures
Design procedures
Records procedures
Customer complaint
procedures
Specifications
Drawings
Advertising literature
Examples of Audit Criteria - External

ISO 9001:2008
Sector specific documents, e.g. ISO/TS 29001

Government regulations and industry codes
Corporate policy
Customer requirements, reflected in the contract
and purchasing specifications
Market and customer requirements for better
products, improved services, or lower prices, that
have been accepted by senior management as
internal goals or requirements
January, 2013
Audit Notification
A unique document for each audit
It should contain:
Purpose or objectives of the audit

Scope and boundaries of the audit
Identification of audit team members
Criteria for the audit
Anticipated start and stop dates and times
Audit interfaces, if any
Provide notification to the auditee well in advance

Notification to auditee can be done by auditor
or audit boss
January, 2013
Relevant Documents
Auditors need to review as much documentation
as can be obtained
Do the documents appear to be adequate?
Have we obtained performance data (from
internal operations and customers)?
How about past audit reports and corrective
action requests?
Do we understand the requirements in
procedures, work instructions, etc.?

January, 2013
Checklist Example: Relevant Documents

ISO 9001:2008
Quality system documentation
Pertinent corporate policies, procedures etc.
Customer specific requirements related to the area
Documented objectives or goals for the area
Procedures and work instructions for the area
Past audit reports
Past and open corrective action requests
Process performance data (e.g. process yields)
Product conformance data
Customer feedback and complaints data
An organization chart
January, 2013
Preparing the Audit Plan

Determine what work papers we will need to
conduct our audit
Prepare work papers
Develop the questions to consider asking

Annotate procedures or work instructions
Do we want/need a checklist?
Is a flowchart of the process to be audited available?
If not, should we make one?
The work papers will be our guide

when we conduct the audit
January, 2013

Typical questions to consider related to the
process input
Do inputs meet specified requirements? How do we know?
Are requirements defined and understood by internal
suppliers?
How is internal supplier performance measured?
Is there a feedback mechanism to suppliers?

January, 2013

Typical questions to consider relating to the process
What are the objectives of the work center, area, process,
activity or product?
How do these relate to the overall objectives of the organization?
Does everyone involved know the customer requirements, as
appropriate (both internal and external)?
Is there an understanding of what is necessary to meet (or
exceed) customer requirements?
Are the individuals performing work correctly? Do they know
what to do and have the means to do it, including
documentation, time and tools? Are applicable procedures
available?
How do individuals know that they have performed work to
requirements?
How is continual improvement addressed?
January, 2013

Typical questions to consider asking relating to
process outputs
Is the process effective in achieving the required results?
How is conformance to customer requirements determined?
Is the process continually improved?
How is customer feedback (external or internal)
solicited and used?

January, 2013

Examples of questions to consider related to
performance improvement
Can this process or some of its activities be
combined with other processes for increased
effectiveness or efficiency?
Evidence of transferable best practices?
Are there redundant or unnecessary activities?
Are there significant risks of future process problems?

January, 2013
Considerations Before the Audit

Clearly defined objectives and scope for the audit?
Team identification and assignments?
Specific audit plan for the audit including timing?
Flowcharts or maps of the processes, areas and activities
about to be examined?
Review and preliminary analysis of the formal
(documented) requirements?
Communication and agreement with the parties about to
be audited?
Work papers prepared to guide the auditors in conducting
the audit?

January, 2013
Have you addressed
Adequacy of documentation vis-a-vis ISO 9001

Competence of personnel
Housekeeping
Objectives of the area you are auditing
Measurements to determine if the process is
meeting requirements
Analysis of data
Records
Correction & corrective action
Improvement
Evidence of meeting requirements
Feedback to suppliers & from customers

January, 2013
To learn more
About the book:
Buy it @ http://www.asq.org/quality-press/
About the authors:

Charlie Cianfrani ([email protected])
Jack West ([email protected])
Dennis R. Arter ([email protected])
About the topic:
Search ASQs Knowledge Center @

http://www.asq.org/knowledge-center/search/
Check out ASQs Standards Central @
http://www.asq.org/standards/
Dont miss part two of this webcast series, which

will cover how to conduct and report on an
audit!
January, 2013

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Auditing Process-based

Quality Management Systems

C. A. Cianfrani & J. E. West

C. A. Cianfrani & J. E. West

C. A. Cianfrani & J. E. West

C. A. Cianfrani & J. E. West

What is an internal audit?

An internal quality audit is an

C. A. Cianfrani & J. E. West

C. A. Cianfrani & J. E. West

Why audit? (continued)

C. A. Cianfrani & J. E. West

C. A. Cianfrani & J. E. West

Audit vs. Management Review vs. Self-assessment

Three complementary concepts:

What do we mean by management review?

C. A. Cianfrani & J. E. West

Three Types of Audits

C. A. Cianfrani & J. E. West

Three Types of Audits

C. A. Cianfrani & J. E. West

Three Types of Audits

C. A. Cianfrani & J. E. West

Three Types of Audits

C. A. Cianfrani & J. E. West

The Process Approach

C. A. Cianfrani & J. E. West

Remember the quality management principles?

Principle #4 Process Approach

Principle #5 System approach to

System: A Family of Well Managed Processes

Network of Interrelated Processes

The SIPOC Model of a Process

The SIPOC model (suppliers, inputs, processes, outputs, customers)

processes from suppliers to final customers

ISO 9001 and Auditing

C. A. Cianfrani & J. E. West

Planning the Audit Program

C. A. Cianfrani & J. E. West

The Audit Process An Overview

Conclusion regarding the conformance of the

C. A. Cianfrani & J. E. West

Administrative Issues to Address

C. A. Cianfrani & J. E. West

Audit principles, procedures and techniques

Consider guidance in ISO 19011

Lead Auditor Criteria

Making an Audit Schedule

List main activities (processes)

C. A. Cianfrani & J. E. West

Audit Process Overview

C. A. Cianfrani & J. E. West

The Audit Process - Overview

C. A. Cianfrani & J. E. West

Planning Individual Audits

C. A. Cianfrani & J. E. West

Prepare for an Audit

Define audit objectives

C. A. Cianfrani & J. E. West